Development of a simple protocol to enhance compliance in home management of malaria

ISRCTN ISRCTN05620936
DOI https://doi.org/10.1186/ISRCTN05620936
Secondary identifying numbers N/A
Submission date
22/10/2007
Registration date
30/10/2007
Last edited
30/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ikeoluwapo Ajayi
Scientific

Department of Epidemiology
Medical Statistics and Environmental Health
College of Medicine
University of Ibadan
Ibadan
PMB 5116
Nigeria

Email ikeajayi2003@yahoo.com

Study information

Study designSingle-centre, single-blind, randomised controlled field study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesMalaria is a disease caused by the protozoan plasmodium falciparum. It is still rampant in sub-Saharan Africa and endemic in Nigeria with perennial transmission. It causes febrile illness which could be severe in children accounting for 25% of infant mortality and 8-12% of death under age of five years. Malaria is responsible for 40-60% of out patient consultation. It presents in two clinical types - uncomplicated and severe malaria.

Study Domain: Parasitic infection; child care and health education/behaviour change

Study hypotheses:
1. There will be no significant difference in the outcome of malaria in children whose mothers or caregivers used treatment protocol to treat malaria at home and those whose mothers did not use the protocol.
2. There will be no significant difference in the correctness of use of chloroquine by mothers who used the treatment protocol and those who did not use the protocol.
3. There will be no significant difference in the correctness of use of chloroquine by trained mothers and mothers who were not trained.
Ethics approval(s)The joint University of Ibadan/University College Hospital Institutional Ethical Review Board. Date of Approval: 29th June 2000
Health condition(s) or problem(s) studiedMalaria
InterventionRandomisation of the communities to the intervention and control groups was done by ballots.

Interventions carried out at the intervention site:
1. Training of 'mother trainers' and community members about cause, symptoms and signs of the clinical types, treatment and prevention of malaria including referral.

2. Development of a treatment protocol using participatory approach and distribution of the protocol to households. The development of the protocol was done in phases using modified focus group sessions with several community checks at different stages of development. The participants were the 'mother trainers', selected community members, research team and a graphic artist. The treatment protocol consists of treatment guidelines for each of the clinical types of malaria compiled together on a cardboard. The protocol illustrated the presentation of clinical types of malaria, the appropriate steps to take for each type and the correct dose and schedule of treatment of uncomplicated malaria using chloroquine according to the age of the child. The protocol was in cartoon format and the local language was used.

Mothers/caregivers in both arms of the study were requested to purchase the chloroquine used for treatment from their regular source which in most instances are the drug hawkers and patent medicine sellers.

Control arm of the study:
They were passive controls. The communities in the control arm of the study were left to continue their usual treatment practice for malaria in their children. No training or guideline was provided.

Duration of intervention: One year
Intervention typeOther
Primary outcome measureThe mothers/caregivers were asked about the treatment given to the child during visits by the research assistants. The mothers/caregivers were asked to record these details in their diary, which was checked on Day 7 from recruitment at the time of collecting Day 7 blood sample for microscopy examination. These data were used to assess the following:

1. Correct use of chloroquine, measured in terms of dose, frequency and duration
2. Timeliness of commencing treatment (commencing treatment within 24 hours of noticing fever in child)
3. Treatment outcome, measured by mean parasite clearance time, fever clearance time, and progression of illness as reported by mothers/caregivers
4. Use of the protocol. Proportion of mothers who referred to the treatment protocol in the treatment of last episode of malaria in children
Secondary outcome measures1. Attack rate of malaria over a period of one year
2. Sensitivity and specificity of presumptive diagnosis of malaria by mothers/caregivers
Overall study start date16/06/2004
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit10 Years
SexBoth
Target number of participants152 children (76 in each arm)
Key inclusion criteria1. Mothers with children 10 years or less who have febrile illness presumed to be malaria
2. Willingness of mothers to allow their child remain in study for a period of 14 days
3. Mothers who consent to their child having finger prick to collect blood for blood smears
Key exclusion criteria1. Child with severe illness or requiring parenteral medication
2. Child with other diseases, co-morbid with febrile illness

Withdrawal Criteria:
1. Parents of children choosing not to continue with the study
2. Progression of illness in child
Date of first enrolment16/06/2004
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • Nigeria

Study participating centre

Department of Epidemiology
Ibadan
PMB 5116
Nigeria

Sponsor information

University of Ibadan (Nigeria)
University/education

c/o Dr Ikeoluwapo Oyeneye Ajayi
Department of Epidemiology
Medical Statistics and Environmental Health
College of Medicine
University of Ibadan
Ibadan
PMB 5116
Nigeria

Phone +234 8 023 268431
Email ikeajayi2003@yahoo.com
Website http://www.ui.edu.ng/
ROR logo "ROR" https://ror.org/03wx2rr30

Funders

Funder type

Other

Investigator funded (Nigeria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan